Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)

FDA 510(k) K260394 · Hangzhou Jimushi Meditech Co., Ltd.

Substantially Equivalent

510(k) numberK260394

Submission

Device name
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)
Applicant
Hangzhou Jimushi Meditech Co., Ltd.
Hangzhou, CN
Received
February 6, 2026
Decision date
June 24, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EZD – Catheter, Straight
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

Other 510(k)s with product code EZD

510(k)DeviceApplicantDecision
K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional Convatec08/05/2026SE
K261658LoFric Origo Pro CoudéEZD · Special Wellspect AB07/17/2026SE
K262045Luja SoftEZD · Special Coloplast A.S.07/07/2026SE
K253295Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional Hollister Incorporated05/18/2026SE
K260999LoFric Elle ProEZD · Special Wellspect AB04/24/2026SE
K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional Convatec Limited04/01/2026SE
K260502Liv Pre-lubricated Intermittent CatheterEZD · Traditional HR Healthcare03/12/2026SE
K251274EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional HR Healthcare01/29/2026SESK
K251178Ready to use Nelaton CatheterEZD · Traditional Jamjoom Fullcare Corporation01/02/2026SE
K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional Hollister Incorporated10/03/2025SE

More from Hollister Incorporated

510(k)DeviceDecision
K222677Intermittent nelaton catheter for single useEZD · Traditional 04/05/2023SE
K200134Jimushi Sterile Urethral Catheter for single useGBM · Traditional 06/01/2020SE

Questions and answers

When was Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) cleared by the FDA?

Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (K260394) received a 510(k) decision of Substantially Equivalent on June 24, 2026, 138 days after the submission was received.

What is the product code of K260394?

The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.